Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components for aspiration and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are non-clinical bench and animal testing, not studies evaluating AI/ML performance metrics.

Therapeutic

Yes
The device is intended for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a direct treatment for a disease condition.

Diagnostic

No

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. It is a treatment device designed to restore blood flow, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a catheter, tubing, pump, and collection canister.

IVD (In Vitro Diagnostic)

Based on the provided information, the Riptide™ Aspiration System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to physically remove blood clots from blood vessels in patients with acute ischemic stroke. This is a therapeutic intervention performed in vivo (within the living body).
Device Description: The device components are designed for mechanical aspiration within the vascular system. They are not used to analyze biological samples in vitro (outside the living body) to provide diagnostic information.
Lack of Diagnostic Function: The system's purpose is to restore blood flow, not to diagnose a condition or provide information about a patient's health status based on the analysis of samples.

IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. The Riptide™ Aspiration System does not perform this function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Product codes

NRY

Device Description

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

Arc™ Catheter .
Riptide™ Aspiration Tubing .
Riptide™ Aspiration Pump ●
Riptide™ Collection Canister with Intermediate Tubing .

The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Data - Bench:
Non-clinical bench testing was performed for each component of the Riptide™ Aspiration System to evaluate the performance of the design modifications. Key results indicate that the Arc™ Catheter, Riptide™ Aspiration Tubing, Riptide™ Aspiration Pump, Riptide™ Canister with Intermediate Tubing, and the integrated Riptide™ Aspiration System all met their respective acceptance criteria for various tests including microbial, packaging, and performance characteristics (e.g., lumen patency, dimensional inspection, vacuum resistance, flow rate, electrical safety, volume capacity, simulated clot retrieval).

Performance Data - Animal:
Non-clinical animal testing was performed to evaluate the safety, efficacy, and usability of the Riptide™ Aspiration System in comparison to the Penumbra System® and Penumbra Pump MAX™ at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. This testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.

Performance Data - Clinical:
Not Applicable. A determination of substantial equivalence is based upon non-clinical bench and animal testing.

Conclusion:
The non-clinical bench and animal testing supports a determination that the subject Riptide™ Aspiration System is substantially equivalent to the predicate Penumbra System® and Penumbra Pump MAX™.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Penumbra System® and Penumbra Pump MAX™ 510(k)#: K160449

Reference Device(s)

Arc™ Intracranial Support Catheter 510(k)#: K150107, Penumbra System®/Penumbra System MAX™ 510(k)#: K133317, Penumbra Pump MAX™ 510(k)#: K122756, Penumbra Reperfusion Catheter 054 510(k)#: K090752

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 21, 2017

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K172448

Trade/Device Name: Riptide™ Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 20, 2017 Received: November 21, 2017

Dear Mr. Ryan Kenney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172448

Device Name Riptide™ Aspiration System

Indications for Use (Describe)

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K172448

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
	9775 Toledo Way
	Irvine, CA 92618
	Establishment Registration No.: 2029214
Contact Person:	Ryan Kenney
	Senior Regulatory Affairs Specialist
	Telephone: (949) 297-5489
	Email: ryan.j.kenney@medtronic.com
Date Summary Prepared:	December 18, 2017
Trade Name of Device:	Riptide™ Aspiration System
Common Name of Device:	Catheter, Thrombus Retriever
Regulation Description:	Percutaneous Catheter
Review Panel:	Neurology
Product Code:	NRY
Regulation Number:	21 CFR 870.1250
Device Classification:	Class II
Predicate Device(s):	Penumbra System® and Penumbra Pump MAX™
	510(k)#: K160449
Reference Device(s):	Arc™ Intracranial Support Catheter
	510(k)#: K150107
	Penumbra System®/Penumbra System MAX™
	510(k)#: K133317
	Penumbra Pump MAX™
	510(k)#: K122756
	Penumbra Reperfusion Catheter 054
	510(k)#: K090752

Device Description:

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

Arc™ Catheter .
Riptide™ Aspiration Tubing .
Riptide™ Aspiration Pump ●
Riptide™ Collection Canister with Intermediate Tubing .

4

The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

Indications for Use:

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

| | Predicate Penumbra System® and
Penumbra Pump MAX™
(K160449) | Subject Riptide™ Aspiration System |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use
(IFU) Statement | Reperfusion Catheters and
Separators:
As part of the Penumbra System®,
the Reperfusion Catheters and
Separators are indicated for use in the
revascularization of patients with
acute ischemic stroke secondary to
intracranial large vessel occlusive
disease (within the internal carotid,
middle cerebral – M1 and M2 | The Riptide™ Aspiration System is
intended for use in the
revascularization of patients with acute
ischemic stroke secondary to
intracranial large vessel occlusive
disease (within the internal carotid,
middle cerebral – M1 and M2
segments, basilar, and vertebral
arteries) within 8 hours of symptom
onset. Patients who are ineligible for |
| | Predicate Penumbra System® and
Penumbra Pump MAX™
(K160449) | Subject Riptide™ Aspiration System |
| | segments, basilar, and vertebral
arteries) within 8 hours of symptom
onset. | intravenous tissue plasminogen
activator (IV t-PA) or who fail IV t-PA
therapy are candidates for treatment. |
| | Penumbra Aspiration Tubing:
As part of the Penumbra System®,
the Penumbra Sterile Aspiration
Tubing is indicated to connect the
Penumbra Reperfusion Catheters to
the Penumbra Pump MAX™.

Device Comparison:

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Biocompatibility:

Biocompatibility was performed for the Arc™ Catheter and the Riptide™ Aspiration Tubing. The Arc™ Catheter is categorized as a limited exposure (in vitro Hemocompatibility
Assay | The Arc™ Catheter did not
result in a decrease in any
blood component as compared
to the reference material. These
results indicate that the cause of
thrombi is not related to the
materials exposed to human
blood during use | No adverse effect on leukocyte
or platelet counts. |

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Riptide™ Aspiration Tubing
Test Description	Results	Conclusions
ISO MEM Elution Using L-929
Mouse Fibroblast Cells	The test article scored '0' at 24,
48 and 72 ± 4 hours and is
considered non-cytotoxic under
the conditions of this test.	Non-cytotoxic.
ISO Guinea Pig Maximization
Sensitization Test	Under the conditions of this
protocol, the test article did not
elicit a sensitization response.	Non-sensitizer.
ISO Intracutaneous Irritation
Test	The differences in the mean test
and control scores of the extract
dermal observations were Microbial
Ethylene Oxide (EO) Residual	EO Residual for the Arc™ Catheter is performed per ISO 10993-7.	The Arc™ Catheter met the acceptance criteria for EO Residual.
Ethylene Chlorohydrin (ECH)	ECH for the Arc™ Catheter is performed per ISO 10993-7.	The Arc™ Catheter met the acceptance criteria for ECH.
Bioburden	Bacterial Endotoxin for the Arc™ Catheter is performed per ANSI/AAMI ST72 and USP 161.	The Arc™ Catheter met the acceptance criteria for Bacterial Endotoxin.
Packaging
Arc™ Catheter
Test	Test Method Summary	Results
Visual Inspection	Visual Inspection for the Arc™ Catheter is performed per ASTM F1886.	The Arc™ Catheter met the acceptance criteria for Visual Inspection.
Bubble Leak	Bubble Leak for the Arc™ Catheter is performed per ASTM F2096.	The Arc™ Catheter met the acceptance criteria for Bubble Leak.
Seal Strength	Seal Strength for the Arc™ Catheter is performed per ASTM F88.	The Arc™ Catheter met the acceptance criteria for Seal Strength.
Performance
Lumen Patency	The proximal hub to the distal tip of the Arc™ Catheter must pass through a stainless-steel mandrel of required size.	The Arc™ Catheter met the acceptance criteria for Lumen Patency.
Dimensional Inspection	The usable length, proximal and distal inner and outer diameter of the Arc™ Catheter is recorded.	The Arc™ Catheter met the acceptance criteria for Dimensional Inspection.
Tip Buckling	The repeated distal tip buckling force under compressive load is evaluated for stiffness.	The Arc™ Catheter met the acceptance criteria for Tip Buckling.
Injection Flow Rate	Injection Flow Rate for the Arc™ Catheter is performed per ISO 10555-1, Annex E with injection through the proximal hub.	The Arc™ Catheter met the acceptance criteria for Injection Flow Rate.
Suction Flow Rate	Suction Flow Rate for the Arc™ Catheter is performed per ISO 10555-1, Annex E with injection through the distal tip.	The Arc™ Catheter met the acceptance criteria for Suction Flow Rate.
Vacuum Resistance	Vacuum Resistance for the Arc™ Catheter is performed under static conditions using a 60cc syringe.	The Arc™ Catheter met the acceptance criteria for Vacuum Resistance.
Air Aspiration Leak	Air Aspiration Leak for the Arc™ Catheter is performed per ISO 10555-1, Annex D.	The Arc™ Catheter met the acceptance criteria for Air Aspiration Leak.
Hub/Shaft Peak Tensile Force	Hub/Shaft Peak Tensile Force for the Arc™ Catheter is performed per ISO 10555-1, Annex B.	The Arc™ Catheter met the acceptance criteria for Hub/Shaft Peak Tensile Force.
Coating Integrity	Coating Integrity for the Arc™ Catheter was assessed using a staining method pre and post.	Characterization only.
ArcTM Catheter
Test	Test Method Summary	Results
Coating Lubricity/Durability	simulation to estimated coating
coverage.	The ArcTM Catheter met the
acceptance criteria for Coating
Lubricity/Durability.
Particulate	Particulate for the ArcTM
Catheter was performed in a
tortuous model per USP .	ArcTM Catheter met the
acceptance criteria for
Particulate.
Kink Resistance	Kink Resistance for the ArcTM
Catheter is performed with the
device wrapped around a rod or
known radius at which point
the ArcTM Catheter is inspected
for kinking.	The ArcTM Catheter met the
acceptance criteria for Kink
Resistance.
Liquid Leak	Liquid Leak for the ArcTM
Catheter is performed per ISO
10555-1, Annex C.	The ArcTM Catheter met the
acceptance criteria for Liquid
Leak.
Static/Dynamic Burst	Static/Dynamic Burst for the
ArcTM Catheter is performed
per ISO 10555-1, Annex F.	The ArcTM Catheter met the
acceptance criteria for
Static/Dynamic Burst.
Corrosion Resistance	Corrosion Resistance for the
ArcTM Catheter is performed
per ISO 10555-1, Annex A.	The ArcTM Catheter met the
acceptance criteria for
Corrosion Resistance.
Torque to Failure	The ArcTM Catheter is
navigated through a tortuous
model where the distal tip is
secured, and the proximal end
of the catheter is rotated 360°.
The total number of 360°
rotations prior to failure is
recorded	Characterization only.

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The following non-clinical bench testing was performed for the Riptide™ Aspiration Tubing:

Riptide™ Aspiration Tubing
Test	Test Method Summary	Results
Microbial
Ethylene Oxide (EO) Residual	EO Residual for the Riptide™ Aspiration Tubing is performed per ISO 10993-7.	The Riptide™ Aspiration Tubing met the acceptance criteria for EO Residual.
Ethylene Chlorohydrin (ECH)	ECH for the Riptide™ Aspiration Tubing is performed per ISO 10993-7.	The Riptide™ Aspiration Tubing met the acceptance criteria for ECH.
Riptide™ Aspiration Tubing
Test	Test Method Summary	Results
Bioburden Recovery	Bioburden Recovery for the
Riptide™ Aspiration Tubing is
performed per
ANSI/AAMI/ISO 11737-1.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Bioburden
Recovery.
Bioburden	Bioburden for the Riptide™
Aspiration Tubing is performed
per ANSI/AAMI/ISO 11737-1.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Bioburden.
Bacterial Endotoxin	Bacterial Endotoxin for the
Riptide™ Aspiration Tubing is
performed per ANSI/AAMI
ST72.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Bacterial Endotoxin.
Packaging
Aseptic Presentation	Aseptic Presentation for the
Riptide™ Aspiration Tubing is
performed for delamination.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Aseptic
Presentation.
Seal Width	Seal Width for the Riptide™
Aspiration Tubing is performed
per ASTM F2203.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Seal Width.
Dye Leak	Dye Leak for the Riptide™
Aspiration Tubing is performed
per ASTM F1929.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Dye Leak.
Visual Inspection	Visual Inspection for the
Riptide™ Aspiration Tubing is
performed per ASTM F1886.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Visual Inspection.
Bubble Leak	Bubble Leak for the Riptide™
Aspiration Tubing is performed
per ASTM F2096.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Bubble Leak.
Legibility	Legibility for the Riptide™
Aspiration Tubing is performed
for smearing or degradation.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Legibility.
Foreign Material	Foreign Material on the
Riptide™ Aspiration Tubing is
performed via visual
inspection.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Foreign Material.
Seal Strength	Seal Strength for the Riptide™
Aspiration Tubing is performed
per ASTM F88.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Seal Strength.
Performance
Dimensional Inspection	The overall and distal length,
proximal and distal inner and
outer diameter of the Riptide™
Aspiration Tubing is recorded.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Dimensional
Inspection
Riptide™ Aspiration Tubing
Test	Test Method Summary	Results
Identification of Heat Shrink
Bands	The heat shrink bands of the
Riptide™ Aspiration Tubing
are visually inspected.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Identification of the
Heat Shrink Bands.
Identification of Flow Switch	The flow switch of the
Riptide™ Aspiration Tubing is
visually inspected.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Identification of the
Flow Switch.
Joint Tensile Strength	The Riptide™ Aspiration
Tubing is affixed to upper and
lower grips of the tensile test
fixture and stretched. The
maximum value before failure
is recorded.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Joint Tensile
Strength.
Leak	The Riptide™ Aspiration
Tubing is pressurized to
specified vacuum pressure and
any decay in pressure is
recorded	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Leak (Vacuum and
Pressure Decay).
Degree of Collapse	Degree of Collapse for the
Riptide™ Aspiration Tubing is
performed per ISO 10079-3.	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Degree of Collapse.
Compatibility	The distal end of the Riptide™
Aspiration Tubing is connected
to the proximal hub of the
Arc™ Catheter. The proximal
end of the Riptide™ Aspiration
Tubing is connected to the
horizontal port of the Riptide™
Collection Canister	The Riptide™ Aspiration
Tubing met the acceptance
criteria for Compatibility to the
Arc™ Catheter and Riptide™
Collection Canister.

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The following non-clinical bench testing was performed for the Riptide™ Aspiration Pump:

Riptide™ Aspiration Pump
Test	Test Method Summary	Results
Degrees of Tilt	The test axes of the Riptide™
Aspiration Pump are pivoted
45° and does not tip over.	The Riptide™ Aspiration Pump
met the acceptance criteria for
Degrees of Tilt.
Durability	The Riptide™ Aspiration Pump
is functional through 500 hours
of expected service life.	The Riptide™ Aspiration Pump
met the acceptance criteria for
Durability.
Maximum Vacuum	The vacuum control valve of
the Riptide™ Aspiration Pump
is set to maximum vacuum and	The Riptide™ Aspiration Pump
met the acceptance criteria for
Maximum Vacuum.

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Riptide™ Aspiration Pump
Test	Test Method Summary	Results
	recorded.
Flow Capacity	The Riptide™ Aspiration Pump
was ran at specified pressure
prior to recording the air flow.	The Riptide™ Aspiration Pump
met the acceptance criteria for
Flow Capacity.
Electrical Safety	Electrical safety for the
Riptide™ Aspiration Pump is
performed per IEC 60601-1.	The Riptide™ Aspiration Pump
met the acceptance criteria for
Electrical Safety
Electromagnetic Compatibility	Electromagnetic compatibility
for the Riptide™ Aspiration
Pump is performed per IEC
60601-1-2.	The Riptide™ Aspiration Pump
met the acceptance criteria for
Electromagnetic Compatibility.

The following non-clinical bench testing was performed for the Riptide™ Canister with Intermediate Tubing:

Riptide™ Collection Canister with Intermediate Tubing
Test	Test Method Summary	Results
Packaging
Packaging Integrity	Packaging Integrity for the
Riptide™ Collection Canister
with Intermediate Tubing is
performed per ISTA 2A and
ATSM D4169.	The Riptide™ Collection
Canister met the acceptance
criteria for Packaging Integrity.
Packaging Labeling	Packaging Labeling for the
Riptide™ Collection Canister
with Intermediate Tubing is
performed to ensure the
labeling remains affixed and
legible over the labeled shelf
life of three (3) months.	The Riptide™ Collection
Canister met the acceptance
criteria for Packaging Labeling.
Performance
Volume Capacity	The Riptide™ Collection
Canister is visually inspected to
ensure graduations up to
1200mL.	The Riptide™ Collection
Canister met the acceptance
criteria for Volume Capacity.
Volume Marking	The Riptide™ Collection
Canister is visually inspected to
ensure graduations in 100mL.	The Riptide™ Collection
Canister met the acceptance
criteria for Volume Marking.
Canister Strength	The Riptide™ Collection
Canister is tested for canister
strength per ISO 10079-3.	The Riptide™ Collection
Canister met the acceptance
criteria for Canister Strength.
Overfill Protection	The Riptide™ Collection
Canister is tested for overfill	The Riptide™ Collection
Canister met the acceptance

15

Riptide™ Collection Canister with Intermediate Tubing
Test	Test Method Summary	Results
Dimensional Inspection	protection per ISO 10079-3.
The overall length of the
Intermediate Tubing is
recorded.	criteria for Overfill Protection.
The Intermediate Tubing met
the acceptance criteria for
Dimensional Inspection.
Degree of Collapse	Degree of Collapse for the
Intermediate Tubing is
performed per ISO 10079-3.	The Intermediate Tubing met
the acceptance criteria for
Degree of Collapse.
Port Identification	The Riptide™ Collection
Canister is visually inspected to
ensure the connection ports are
correctly labeled.	The Riptide™ Collection
Canister met the acceptance
criteria for Port Identification.
Compatibility	The Intermediate Tubing is
connected to the vacuum inlet
port of the Riptide™ Aspiration
Pump.	The Intermediate Tubing met
the acceptance criteria for
Compatibility.

The following non-clinical bench testing was performed for the Riptide™ Aspiration System:

Riptide™ Aspiration System
Test	Test Method Summary	Results
Simulated Clot Retrieval	The Arc™ Catheter is navigated through a tortuous model to the intended treatment location for simulated clot retrieval.	The Riptide™ Aspiration System met the acceptance criteria for Simulated Clot Retrieval.
Vacuum Pressure	The vacuum pressure experienced at the distal tip of the Arc™ Catheter is recorded.	The Riptide™ Aspiration System met the acceptance criteria for Vacuum Pressure.
Flow Rate	The flow rate through the Arc™ Catheter is recorded under full-flow conditions.	The Riptide™ Aspiration System met the acceptance criteria for Flow Rate.
Lumen Collapse	The Arc™ Catheter is navigated through a tortuous model and subjected to maximum vacuum pressure generated by the Riptide™ Aspiration Pump at which point the catheter is inspected for any collapse or damage.	The Arc™ Catheter is resistant to Lumen Collapse.
Usability	The Penumbra System® and Penumbra Pump MAX™ and the Riptide™ Aspiration System were evaluated for navigability, flexibility, the	The Riptide™ Aspiration System met the acceptance criteria for Usability.

16

Riptide™ Aspiration System
Test	Test Method Summary	Results
	ability to engage and apply
aspiration, and for the ability to
safely retrieve clot by end
users.

The non-clinical bench testing, as described above, indicates that the Riptide™ Aspiration System is substantially equivalent to the Penumbra System® and Penumbra Pump MAXTM.

Performance Data - Animal:

Non-clinical animal testing was performed to evaluate the safety, efficacy, and usability of the Riptide™ Aspiration System in comparison to the Penumbra System® and Penumbra Pump MAX™ at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. Non-clinical animal testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.

The non-clinical animal testing, as described above, indicates that the Riptide™ Aspiration System is substantially equivalent to the Penumbra System® and Penumbra Pump MAXTM.

Performance Data - Clinical:

Not Applicable. A determination of substantial equivalence is based upon non-clinical bench and animal testing.

Conclusion:

The design modifications incorporated into the Riptide™ Aspiration System do not alter the fundamental scientific technology or intended use.

Non-clinical bench and animal testing supports a determination that the subject RiptideTM Aspiration System is substantially equivalent to the predicate Penumbra System® and Penumbra Pump MAX™.